Gur­net Point-backed Au­re­gen taps Am­gen vet to lead; Ex-Roche RNA chief takes CEO post at Genevant

Gur­net Point Cap­i­tal-backed Au­re­gen Bio­Ther­a­peu­tics has tapped Am­gen vet Richard Davies to lead its rare dis­ease cell ther­a­py’s en­try in­to the clin­ic as CEO. Davies, a for­mer Hos­pi­ra chief com­mer­cial of­fi­cer who had his first chief ex­ec­u­tive ex­pe­ri­ence re­cent­ly at Bone­sup­port, will lead the dri­ve in trans­lat­ing the Gene­va-based biotech’s 3D bio­fab­ri­ca­tion tech­nolo­gies to new ther­a­peu­tics, start­ing from a pro­gram in rare con­gen­i­tal cran­io­fa­cial dis­or­ders.

→ Brick­ell Biotech has hired in­dus­try vet­er­an and Lil­ly $LLY Chief Mar­ket­ing Of­fi­cer Robert Brown to take the reins at the der­ma­tol­ogy com­pa­ny as it preps a late-stage tri­al eval­u­at­ing its drug, sof­piro­ni­um bro­mide, in pa­tients with ex­ces­sive un­der­arm sweat­ing in the first half of 2019. Brown, who has spent over three decades at Lil­ly, is set to re­place Brick­ell’s cur­rent CEO and co-founder Regi­nald Hardy on Jan­u­ary 1.

Bo Rode Hansen is step­ping up from a CSO po­si­tion to take the top job at Genevant. Un­like the rest of Vivek Ra­maswamy’s biotech fam­i­ly, the com­pa­ny is not in-li­cens­ing late-stage pro­grams, but build­ing a pipeline from scratch us­ing Ar­bu­tus’ RNA tech, with the aim of de­liv­er­ing more than five in-house and part­nered can­di­dates for clin­i­cal de­vel­op­ment by 2020. Hansen, the for­mer glob­al head of RNA at Roche with 50 dis­cov­ery pro­grams un­der his belt, will play a lead­ing role along­side a sea­soned ex­ec team.

→ A year af­ter Mary Szela left the helm of Nov­e­l­ion Ther­a­peu­tics $NVLN, the rare dis­ease biotech is shak­ing up its CEO of­fice again. Jef­frey Hack­man, the for­mer COO who’s been fill­ing in, has re­signed as in­ter­im CEO, pass­ing the re­spon­si­bil­i­ties to gen­er­al coun­sel Ben­jamin Harsh­barg­er. Hav­ing helped se­cure a re­cent loan fa­cil­i­ty, Harsh­barg­er is charged with the grand turn­around mis­sion by first fix­ing the cap­i­tal struc­ture.

→ Al­most a year af­ter step­ping down from Syn­er­gy Phar­ma­ceu­ti­cals — a com­pa­ny he found­ed and co-in­vent­ed the lead drug for — Gary Ja­cob has land­ed at a mi­cro­bio­me biotech in Aus­tralia. As CEO, Ja­cob is ex­pect­ed to chan­nel both his de­vel­op­ment, fi­nan­cial and com­mer­cial ex­per­tise in steer­ing Im­muron’s $IM­RN pipeline of oral­ly de­liv­ered poly­clon­al an­ti­bod­ies, which is led by a pro­gram for liv­er dis­eases.

→ Fol­low­ing a wide-rang­ing ca­reer fea­tur­ing stints at No­var­tis, L’Ore­al and SBM Man­age­ment Ser­vices, Stephan Jack­man has been ap­point­ed CEO of Alza­mend Neu­ro, a biotech de­vel­op­ing a cou­ple of Alzheimer’s drug can­di­dates out of the Uni­ver­si­ty of South Flori­da. Pri­or to the new role, Jack­man was fo­cused on ad­vanc­ing cures for mos­qui­to borne in­fec­tious dis­eases as COO of En­naid Ther­a­peu­tics.

→ New­ly pub­lic Ma­gen­ta Ther­a­peu­tics $MG­TA has scooped Ja­son Ryan from Foun­da­tion Med­i­cine to be its chief op­er­at­ing and fi­nan­cial of­fi­cer. The high fly­ing Cam­bridge start­up, which has a port­fo­lio fo­cused on bone mar­row trans­plant, can ben­e­fit from Ryan’s ex­pe­ri­ence in cap­i­tal cre­ation and al­lo­ca­tion as well as com­mer­cial plan­ning, says CEO Ja­son Gard­ner, as demon­strat­ed in his ef­forts with Foun­da­tion’s re­cent sale to Roche.  

→ Gothen­burg, Swe­den-based Iso­fol has hired Roger Tell — a bio­phar­ma vet who’s al­so run mul­ti­ple tri­als as a prin­ci­pal in­ves­ti­ga­tor — to run its clin­i­cal pro­gram as it ad­vances its lead prod­uct can­di­date in­to Phase III. Ar­foli­tixorin, de­vel­oped through a part­ner­ship with Mer­ck KGaA, is de­signed to boost the ef­fects of chemother­a­py main­ly in col­orec­tal can­cer. As CSO and SVP of clin­i­cal de­vel­op­ment, Tell will al­so over­see  sci­en­tif­ic re­search and tech­ni­cal op­er­a­tions.

→ With its Phase III pro­grams well un­der­way, Apel­lis Phar­ma­ceu­ti­cals $APLS has tapped Adam Townsend to plot a mar­ket­ing plan for APL-2 — its com­ple­ment C3 in­hibitor look­ing to ri­val Soliris in parox­ys­mal noc­tur­nal he­mo­glo­bin­uria — and al­so build a fran­chise in ge­o­graph­ic at­ro­phy, an ad­vanced form of age-re­lat­ed mac­u­lar de­gen­er­a­tion. The new chief com­mer­cial joins from Bio­gen, where he helped lead the launch­es of Tec­fidera and Spin­raza.

→ Fol­low­ing an 11-year ca­reer run­ning clin­i­cal op­er­a­tions for mul­ti­ple units — in­clud­ing the oph­thalmic fran­chise — at No­var­tis, Fabio Baschiera is jump­ing to an oph­thal­mol­o­gy start­up backed by the phar­ma gi­ant. His new ti­tle at Oculis will be VP of clin­i­cal de­vel­op­ment. Al­so join­ing the Swiss biotech: Louie-Anne Gau­thi­er, who will now scout deals for Oculis’ eye drop al­ter­na­tives for in­jectable drugs as its VP of strate­gic mar­ket­ing, busi­ness de­vel­op­ment and li­cens­ing.

Daphne Koller, Getty

Bris­tol My­er­s' Richard Har­g­reaves pays $70M to launch a neu­rode­gen­er­a­tion al­liance with a star play­er in the ma­chine learn­ing world

Bristol Myers Squibb is turning to one of the star upstarts in the machine learning world to go back to the drawing board and come up with the disease models needed to find drugs that can work against two of the toughest targets in the neuro world.

Daphne Koller’s well-funded insitro is getting $70 million in cash and near-term milestones to use their machine learning platform to create induced pluripotent stem cell-derived disease models for ALS and frontotemporal dementia.

Eli Lilly CEO David Ricks at the Rose Garden, May 26, 2020 (Evan Vucci/AP Images)

Eli Lil­ly lines up a block­buster deal for Covid-19 an­ti­body, right af­ter it failed a NI­AID tri­al

Two days after Eli Lilly conceded that its antibody bamlanivimab was a flop in hospitalized Covid-19 patients, the US government is preparing to make it a blockbuster.

The pharma giant reported early Wednesday that it struck a deal to supply the feds with 300,000 vials of the drug at a cost of $375 million — once it gets an EUA stamp from the FDA. And once that 2-month supply deal is done, the government has an option on another 650,000 doses on the same terms — which could potentially add another $812 million.

Eli Lilly CEO David Ricks (Evan Vucci/AP Images)

A P val­ue of 0.38? NE­JM re­sults raise new ques­tions for Eli Lil­ly's vaunt­ed Covid an­ti­body

Generally, a P value of 0.38 means your drug failed and by a fair margin. Depending on the company, the compound and the trial, it might mean the end of the program. It could trigger layoffs.

For Eli Lilly, though, it was part of the key endpoint on a trial that landed them a $1.2 billion deal with the US government to supply up to nearly 1 million Covid-19 antibodies.

So what does one make of that? Was the endpoint not so important, as Lilly maintains? Or did the US government promise a princely sum for a pedestrian drug?

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Ar­cus and As­traZeneca part­ner on a high stakes an­ti-TIG­IT/PD-L1 PhI­II can­cer study, look­ing to im­prove on a stan­dard of care

For AstraZeneca, the PACIFIC trial in Stage III non-small cell lung cancer remains one of the big triumphs for AstraZeneca’s oncology R&D group. It not only made their PD-L1 Imfinzi a franchise player with a solid advance in a large niche of the lung cancer market, the study — which continues to offer data on the long-range efficacy of their drug — also helped salve the vicious sting of the failure of the CTLA-4 combo in the MYSTIC study.

No­var­tis buys a new gene ther­a­py for vi­sion loss, and this is one pre­clin­i­cal ven­ture that did­n't come cheap

Cyrus Mozayeni got excited when he began to explore the academic work of Ehud Isacoff and John G. Flannery at UC Berkeley.

Together, they were engaged in finding a gene therapy approach to pan-genotypic vision restoration in patients with photoreceptor-based blindness, potentially restoring the vision of a broad group of patients. And they did it by using a vector to deliver the genetic sequence for light sensing proteins.

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CMO Merdad Parsey (Gilead)

Gilead hits the brakes on a tri­fec­ta of mid- and late-stage stud­ies for their trou­bled fil­go­tinib pro­gram. It's up to the FDA now

Gilead $GILD execs haven’t decided exactly what to do with filgotinib in the wake of the slapdown at the FDA on their rheumatoid arthritis application, but they’re taking a time out for a slate of studies until they can gain some clarity from the agency. And without encouraging guidance, this drug could clearly be axed from the pipeline.

In their Q3 report out Wednesday afternoon, the company says researchers have “paused” a Phase III study for psoriatic arthritis along with a pair of Phase II trials for ankylosing spondylitis and uveitis. Late-stage studies for ulcerative colitis and Crohn’s are continuing, but you can see for yourself how big a hole this leaves in the inflammatory disease pipeline, with obvious implications if the company abandons filgo altogether.

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Patrick Soon-Shiong at the JP Morgan Healthcare Conference, Jan. 13, 2020 (David Paul Morris/Bloomberg via Getty Images)

Af­ter falling be­hind the lead­ers, dissed by some ex­perts, biotech show­man Patrick Soon-Sh­iong fi­nal­ly gets his Covid-19 vac­cine ready for a tri­al. But can it live up to the hype?

In January, when dozens of scientists rushed to start making a vaccine for the then-novel coronavirus, they were joined by an unlikely compatriot: Patrick Soon-Shiong, the billionaire doctor most famous for making big, controversial promises on cancer research.

Soon-Shiong had spent the last 4 years on his “Cancer Moonshot,” but part of his project meant buying a small Seattle biotech that specialized in making common-cold vectors, called adenoviruses, to train the immune system. The billionaire had been using those vectors for oncology, but the company had also developed vaccine candidates for H1N1, Lassa fever and other viruses. When the outbreak began, he pivoted.

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Jude Samulski, Marianne De Backer

Bay­er buys a biotech ‘race horse’ with a $4B deal — $2B in cash — aimed at go­ing big in­to gene ther­a­py

In the latest sign that Big Pharma wants a leading place in the push to develop a new generation of cell and gene therapies, Bayer is stepping up today with a $2 billion cash deal to buy out one of the fast-moving pioneers in the field, while adding up to $2 billion more in milestones if the new pharma subsidiary can deliver the goods.

As part of a continuing series of deals engineered by Bayer BD chief Marianne De Backer, the pharma player has snapped up Asklepios, more commonly referred to in more casual fashion as AskBio. And they are paying top dollar for a Research Triangle Park-based company that raised $225 million a little more than a year ago to back the brainchild of Jude Samulski, the gene therapy pioneer out of the University of North Carolina Gene Therapy Center.

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Noubar Afeyan, Flagship founder and CEO (Victor Boyko/Getty Images)

UP­DAT­ED: Flag­ship launch­es Sen­da Bio­sciences with $88M in back­ing, look­ing to pi­o­neer the field of 'In­ter­sys­tems Bi­ol­o­gy'

Flagship Pioneering has a fresh company out this week, one that aims to lay the groundwork for a whole new discipline.

Senda Biosciences launched Wednesday with $88 million in Flagship cash. The goal? Gain insights into the molecular connections between people and coevolved nonhuman species like plants and bacteria, paving the way for “Intersystems Biology.”

Guillaume Pfefer has been tapped to run the show, a 25-year biotech veteran who comes from GSK after leading the development of the company’s shingles vaccine.